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Efficacy of Two Intermittent Subglottic Secretion

Primary Purpose

Ventilator Associated Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subglottic secretion lavage combined with aspiration
Subglottic secretion aspiration
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring ventilator-associated pneumonia, subglottic secretion drainage, endotracheal tube, length of mechanical ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)

Exclusion Criteria:

  • Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lavage combined with aspiration

    Pure aspiration

    Arm Description

    Intermittent subglottic secretions lavage combined with aspiration

    Intermittent subglottic secretions aspiration

    Outcomes

    Primary Outcome Measures

    Incidence of ventilator-associated pneumonia
    is pneumonia that occurs when an artificial airway is established and mechanically ventilated

    Secondary Outcome Measures

    Incidence of draining duct blockage
    If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion

    Full Information

    First Posted
    February 19, 2019
    Last Updated
    March 11, 2019
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03871985
    Brief Title
    Efficacy of Two Intermittent Subglottic Secretion
    Official Title
    Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease:A Single-center Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2019 (Anticipated)
    Primary Completion Date
    December 30, 2019 (Anticipated)
    Study Completion Date
    January 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease
    Detailed Description
    Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator Associated Pneumonia
    Keywords
    ventilator-associated pneumonia, subglottic secretion drainage, endotracheal tube, length of mechanical ventilation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    234 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lavage combined with aspiration
    Arm Type
    Experimental
    Arm Description
    Intermittent subglottic secretions lavage combined with aspiration
    Arm Title
    Pure aspiration
    Arm Type
    Active Comparator
    Arm Description
    Intermittent subglottic secretions aspiration
    Intervention Type
    Procedure
    Intervention Name(s)
    Subglottic secretion lavage combined with aspiration
    Intervention Description
    Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O.
    Intervention Type
    Procedure
    Intervention Name(s)
    Subglottic secretion aspiration
    Intervention Description
    Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed.
    Primary Outcome Measure Information:
    Title
    Incidence of ventilator-associated pneumonia
    Description
    is pneumonia that occurs when an artificial airway is established and mechanically ventilated
    Time Frame
    through study completion, an average of 10 months
    Secondary Outcome Measure Information:
    Title
    Incidence of draining duct blockage
    Description
    If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion
    Time Frame
    through study completion, an average of 10 months
    Other Pre-specified Outcome Measures:
    Title
    length of mechanical ventilation
    Description
    length of mechanical ventilation
    Time Frame
    through study completion, an average of 10 months
    Title
    The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract
    Description
    The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract
    Time Frame
    through study completion, an average of 10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage) Exclusion Criteria: Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and

    12. IPD Sharing Statement

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    Efficacy of Two Intermittent Subglottic Secretion

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